The U.S. Food and Drug Administration has approved medical-device maker Olympus' redesigned duodenoscopes. The agency said the changes aim to lower the risk of infections through contamination.
In February, Olympus will begin recalling its TJF-Q180V model duodenoscope from an estimated 4,400 healthcare facilities.
Scopes made by Olympus and other manufacturers have been linked to 25 infection incidents between 2012 and 2015 in the U.S., where as many as 250 patients acquired antibiotic-resistant infections, according to a Senate committee minority staff report released this week.
Modifications to Olympus' scope aim to prevent leaking believed to increase infection risk.
The FDA notified Olympus in March 2014 that it would have to apply for approval of modifications it had made without first notifying the federal agency. Olympus submitted an application for approval in October.
“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” Dr. William Maisel, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, said in a written statement.
In August, the FDA cited Olympus, along with fellow devicemakers Fujifilm and Pentax parent company Hoya Corp., with failures in the production of the devices. The agency said the companies also failed to properly handle reports of adverse events.
And last October, regulators ordered all three companies to conduct post-market research on how effective their disinfecting instructions for those devices were in a medical setting. Hospitals where infections associated with the scopes took place argue the manufacturers didn't provide solid instructions on how to disinfect the scopes.
The devices are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures annually in the U.S. The procedure is a minimally invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.
The FDA has maintained the benefits of ERCPs outweigh the potential risk of contamination from the endoscopes. But the agency acknowledged the device's complex design made the risk of contamination possible even when cleaning instructions were correctly followed.
“Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible,” the agency stated in an alert issued in February.
Olympus is expected to send out notices on Friday to facilities that own the TJF-Q180V model. The letter will offer instructions on returning the device free of charge. The company estimates a four-day turnaround to make the changes.
The FDA advises healthcare facilities can continue to use the Olympus TJF-Q180V model while they wait for the repairs, but caution to strictly follow the manufacturer's reprocessing instructions.
